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Product SKU: ITNTIME46962
[STORAGE AND STABILITY]
●Store as packaged in the sealed pouch at temperature (4-30℃ or 40-86℉). The kit is stable wihin the expiration date printed on the labeling. ●Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration. ●The LOT and the expiration date were printed on the labeling. [SPECIMEN] ●The test can be used to test Whole Blood/Serum/Plasma specimens. ●To collect whole blood, serum or plasma specimens following regular clinical laboratory procedures. ●Separate serum or plasma from blood as soon as possible to avoid hemolysis. Use only clear non-hemolyzed specimens. ●Store specimens at 2-8℃ (36-46℉) if not tested immediately. Store specimens at 2-8℃ up to 7 days. The specimens should be frozen at -20℃ (-4℉) for longer storage. Do not freeze whole blood specimens. ●Avoid multiple freeze-thaw cycles. Prior to testing, bring frozen specimens to room temperature slowly and mix gently. Specimens containing visible particulate matter should be clarified by centrifugation before testing. ●Do not use samples demonstrating gross lipemia, gross hemolysis or turbidity in order to avoid interference on result interpretation.
[TEST PROCEDURE]
Allow the test device and specimens to equilibrate to temperature (15-30℃ or 59-86℉) prior to testing. 1. Bring the pouch to room temperature before opening it. Remove the test cassette from the sealed pouch and use it as soon as possible. 2. Place the test cassette on a clean and level surface. 3. For IgG/IgM Test: Hold the dropper vertically and transfer 1 drop of specimen (approximately 10ul) to the specimen well(S) of the test cassette, then add 2 drops of buffer (approximately 70pu) and start the timer. 4. For NS1Test: For serum or plasma specimen: Hold the dropper verically and transfer 8-10 drops of serum or plasma (approximately 100u) to the specimen well(S) of the test cassette, then start the timer. For whole blood specimens: Hold the dropper vertically and transfer 3 drops of whole blood(approximately 35μl) to the specimen well(S) of the test cassette, then add 2 drops of buffer (approximately 70ul) and start the timer. 5. Wait for the colored line(s) to appear. Read results at 15 minutes. Do not interpret the result after 20 minutes.
[INTERPRETATION OF RESULTS]
Positive: For lgG/IgM Test: Control line and at least one test line appear on the membrane. The appearance of IgG test line indicates the presence of dengue specific lgG antibodies. The appearance of lIgM test line indicates the presence of dengue specific lIgM antibodies. And if both lgG and lgM line appear, it indicates that the presence of both dengue specific lgG and IgM antibodies. For NS1 Test: Two lines appear. One line should always appear in the control line region(C), and another one apparent colored line should appear in the NS1 line region. Negative: One colored line appears in the control region(C). No apparent colored line appears in the test line region. Invalid: Control line fails to appear, Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette.If the problem persists, discontinue using the test kit immediately and contact your local distributor.